New study to uncover hidden heart risks of hormone therapy in transgender individuals
NCT ID NCT07394400
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This observational study will follow 94 transgender individuals for 12 months to see how gender-affirming hormone therapy affects their mood, stress, and heart health. Researchers will measure inflammation, blood vessel function, and other markers to understand potential cardiovascular risks. The goal is to improve healthcare for transgender people by providing clearer information on the benefits and risks of hormone therapy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gender-affirming hormone therapy
- What this could lead to
- If successful, this study could help doctors better understand the risks and benefits of hormone therapy for transgender individuals, leading to safer and more personalized care.
- What could go wrong
- This is an observational study, not a treatment trial. It will not prove cause and effect, and results may take years to influence medical guidelines.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 94 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Transgender individuals referred to a Gender Identity Unit who are requesting Gender Affirmation Hormone Therapy for the first time. It will consist of three visits: at the start, and after 6 and 12 months of treatment.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Trans men and trans women over the age of 16 Exclusion Criteria: * systemic inflammatory diseases * uncontrolled infections * severe autoimmune diseases intersex biological conditions (resistance, severe sexual development or chromosomal abnormalities, congenital adrenal hyperplasia) * treatment with metformin, statins or oral contraceptives in the previous 6 months * serious life-threatening diseases * diseases that compromise follow-up * BMI higher than 35
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Universitario Doctor Peset
Valencia, Valencia, 46017, Spain
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